Metrolab Blog

Using a Risk Assessment to Build a Monitoring System focusing on Data Integrity

In this free webinar, Jason Kelly, VP of Services for Lighthouse Worldwide Solutions will discuss how to apply a Risk Assessment and build a particle monitoring system for your cleanroom. This can be accomplished by applying risk management techniques to successfully design a complete system based on GAMP guidelines.

Jason will review how to select the “right” sample locations in order to provide the data required to empower users to make informed decisions about manufacturing process trends, as well as to intervene in a timely manner when appropriate alarms are triggered.

Jason will also review how to incorporate meaningful alarms and trends, as well as how to use Statistical Process Control in particle alarming techniques in order to develop and maintain a paperless and continuous watchdog warning system.

This system will provide you with assurance that your sterile environment has remained intact during production runs, thereby helping ensure your product quality and safety.

To Register for the European Webinar:
11:00 AM – 12:00 PM / Wednesday, October 30th (GMT),
45 Minute Webinar / 15 Minute Q&A,
Click HERE.

All attendees questions will be addressed during the webinar Q&A and after by direct email.

Webinar Overview

  • Understand how to develop a Risk Assessment
  • Design a suitable Environmental Monitoring System
  • Select the right sample locations
  • Follow GAMP guidelines for the system life cycle
  • Review and validate the data integrity of the sensors and system
  • Learn how to set appropriate system alarms
  • Understand the data to ensure your sterile environment has remained intact.